The present invention relates generally to surgical instruments, and more specifically to devices for the suturing of punctures in blood vessels, internal organs and internal tissues accessed via a tissue tract.
Many surgical procedures require the insertion of catheters and/or surgical devices into blood vessels and other internal structures. For example, in the treatment of vascular disease, it is often necessary to insert an instrument such as a catheter into the blood vessel to perform the treatment procedure. Such treatment procedures often involve piercing a wall of the blood vessel, inserting an introducer sheath into the blood vessel via the opening, and maneuvering the procedural catheter through the introducer sheath to a target location within the blood vessel. Of course in order to complete such a procedure, the opening in the wall of the blood vessel must be sealed to prevent bleeding while facilitating healing of the wound. This sealing has commonly been accomplished by the application of direct pressure over the puncture site by a physician or other trained medical professional. However, this technique is time consuming and may lead to complications such as thrombosis, which may be dangerous to the patient.
Other sealing techniques include the application of a sealing member or plug of material (most often biogenic sealing material) over the opening in the blood vessel to seal the wound. However, proper placement of sealing members and plugs is difficult to achieve and materials left inside the body may pose serious health risks to the patient if, for example, the material enters the blood stream.
The present invention is directed to a device for sealing a puncture in an anatomical structure comprising a proximal portion having a first needle lumen extending therethrough to a first needle opening, a distal portion including a second needle opening facing the first needle opening across a tissue receiving gap and opening into a second needle lumen and a connecting portion coupled between the proximal and distal portions and offset from the proximal and distal portions to create the tissue receiving gap whereby, when the connecting portion is received within a puncture in an anatomical structure, a portion of the anatomical structure received within the tissue receiving gap is located on one side of a plane including a central axis of the puncture.
In addition, the present invention is directed to a method for sealing an opening in an anatomical structure comprising the steps of inserting into the opening a device including a needle exit opening and a needle entry opening separated by a tissue receiving gap and positioning the device so that the needle exit opening is located on a proximal side of the anatomical structure and the needle entry opening is located on a distal side of the anatomical structure with a first portion of the anatomical structure received within the tissue receiving gap. A first needle coupled to a first portion of suture is inserted distally through the device to exit the device via the needle exit opening, penetrate the first portion of the anatomical structure and reenter the device via the needle entry lumen and the device is rotated so that a second portion of the anatomical structure is located within the tissue receiving gap between the needle exit and needle entry lumens. Then a second needle coupled to a second portion of suture is inserted distally through the device to exit the device via the needle exit opening, penetrate the second portion of the anatomical structure and re-enter the device via the needle entry lumen. the device is withdrawn from the anatomical structure and the first and second portions of suture are tightened to draw the sides of the opening together.